Last Updated : May 3, 2024
Details
Generic Name:
alectinib
Project Status:
Active
Therapeutic Area:
ALK-positive NSCLC
Manufacturer:
Hoffmann-La Roche Limited
Call for patient/clinician input open:
Brand Name:
Alecensaro
Project Line:
Reimbursement Review
Project Number:
PC0350-000
Call for patient/clinician input closed:
Tumour Type:
Lung
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Alecensaro as adjuvant treatment following tumour resection in adult patients with Stage IB (4 cm) - IIIA (according to AJCC/UICC 7th edition) anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer.
Submission Type:
Initial
Companion Diagnostics:
Yes
Fee Schedule:
Schedule A
Indications:
Alecensaro as adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | March 06, 2024 |
|---|---|
| Call for patient/clinician input closed | April 30, 2024 |
| Clarification: - Patient input submission received from Lung Cancer Canada and the Lung Health Foundation / Ontario Lung Association | |
| Submission received | April 18, 2024 |
| Submission accepted | May 03, 2024 |
| Review initiated | May 06, 2024 |
| Draft CADTH review report(s) provided to sponsor for comment | July 19, 2024 |
| Deadline for sponsors comments | July 30, 2024 |
| CADTH review report(s) and responses to comments provided to sponsor | August 29, 2024 |
| Expert committee meeting (initial) | September 11, 2024 |
| Draft recommendation issued to sponsor | September 23, 2024 To September 25, 2024 |
| Draft recommendation posted for stakeholder feedback | October 03, 2024 |
| End of feedback period | October 18, 2024 |
Last Updated : May 3, 2024